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RAPITIL 2.0% W/V EYE DROPS SOLUTION

Active substance(s): NEDOCROMIL SODIUM

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Packaging Administration
SANOFI WINTHROP INDUSTRIE - Le Trait - France
Article
Brand name Rapitil
Leaflet
Item code 522013
Dosage
20 mg/ml
Based on 520438
Quantity
5ml
GMID code 606210
Manuf. site
Le Trait
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What Rapitil Eye Drops are and what they are used for
2. Before you use Rapitil Eye Drops
3. How to use Rapitil Eye Drops
4. Possible side effects
5. How to store Rapitil Eye Drops
6. Further information
1. What Rapitil Eye Drops are and what they are used for
What Rapitil Eye Drops are
Rapitil 2% Eye Drops (called Rapitil Eye Drops in this leaflet) contain a
medicine called nedocromil sodium. This belongs to a group of medicines
called anti-allergics.
How Rapitil Eye Drops work
It works by stopping the release of the natural substances in your eyes that
can lead to an allergic reaction.

Date of creation
04/06/2015
By
F Nguyen
Date of modification By
Proof n°
1
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

2531
TRA-P040210c
TRA-P040210-1b
270x125 flat
22,5x125 folded

What Rapitil Eye Drops can be used for
Stopping, treating and relieving the symptoms of ‘allergic conjunctivitis’
(inflammation of parts of the eye). Rapitil Eye Drops can be used for three
types of allergic conjunctivitis:
• ‘Perennial allergic conjunctivitis’ in adults only: This type of allergy
can happen at any time of the year and is often caused by animal fur or
house dust mites. Signs include itchy, watery, red or inflamed eyes and
puffy eyelids.
• ‘Seasonal allergic conjunctivitis’ in adults and children: This type of
allergy, such as hay fever, can be caused by different pollens in different
seasons of the year. Signs include itchy, watery, red or inflamed eyes and
puffy eyelids.
• ‘Vernal kerato conjunctivitis’ in adults and children: This is a more
severe type of allergy. Signs include bumps inside the upper eyelid,
sensitivity to light and severe itching
2. Before you use Rapitil eye drops
Do not use this medicine and tell your doctor or pharmacist if:
You are allergic (hypersensitive) to nedocromil sodium, or any of the other
ingredients of Rapitil Eye Drops (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue or around the eyes
Do not use this medicine if the above applies to you. If you are not sure, talk
to your doctor or pharmacist before using Rapitil Eye Drops.

Take special care with Rapitil Eye Drops if:
You wear soft contact lenses. You should not wear soft contact lenses while
using these drops
If you are not sure if this applies to you, talk to your doctor or pharmacist
before using Rapitil Eye Drops.
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant, might
become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your doctor or
pharmacist before taking or using any medicine.

Pharmacode
Brandmark/name
Country example
Font size

147
A1 - 03.10.2006
CRGB - V1 - 05/2012
8 pt
Plan

Driving and using machines
Your eyesight may be affected after using this medicine. If this happens, do
not drive or use any tools or machines until you can see clearly.
Important information about some of the ingredients of Rapitil Eye Drops
Rapitil Eye Drops contain benzalkonium chloride. This may cause your eyes
to become irritated. It may also change the colour of your contact lenses.
3. How to use Rapitil Eye Drops
Always use Rapitil Eye Drops exactly as your doctor or pharmacist has told
you. You should check with your doctor or pharmacist if you are not sure.
Using this medicine
• If you wear hard or gas-permeable contact lenses, you should take them
out while you use the eye drops. You should wait 15 minutes before you
put the contact lenses back in
• If you need to use more than one type of eye medicine, the medicines
must be used at least 5 minutes apart. Eye ointments should be used last.
• If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor or pharmacist
How to use this medicine
• Wash your hands
• Remove the cap from the bottle
• Tilt your head back
• Squeeze one or two drops inside the
lower lid without touching your eye
• Close your eye
• Wipe away any excess liquid from
the eyes with a clean tissue
• Always put the cap back on the
bottle as soon as you have used it
• Repeat in the other eye as needed
How much to use
Adults, Elderly and Children aged 6 years and over
Seasonal allergic conjunctivitis:
• One drop into each eye twice each day
• This can be increased to four times each day if needed
• Do not use for more than 12 weeks
Vernal kerato-conjunctivitis
• One drop into each eye four times each day

Packaging Administration
SANOFI WINTHROP INDUSTRIE - Le Trait - France
Article
Brand name Rapitil
Leaflet
Item code 522013
Dosage
20 mg/ml
Based on 520438
Quantity
5ml
GMID code 606210
Manuf. site
Le Trait
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

2531
TRA-P040210c
TRA-P040210-1b
270x125 flat
22,5x125 folded

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

Pharmacode
Brandmark/name
Country example
Font size

147
A1 - 03.10.2006
CRGB - V1 - 05/2012
8 pt
Plan

5. How to store Rapitil Eye Drops
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Rapitil Eye Drops after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of that month.
Store below 25°C. Keep the bottle in the outer carton in order to protect
from light.
Rapitil Eye Drops are sterile when you buy them, so you must not keep them
for more than four weeks after opening the bottle.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

Manufacturer
Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait, France
This leaflet does not contain all the information about your medicine. If
you have any questions or are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in May 2015
© Sanofi, 1995 - 2015

6. Further information
What Rapitil Eye Drops contain
• The solution contains 2% w/v of the active substance, nedocromil sodium
• The other ingredients are disodium edetate, benzalkonium chloride,
sodium chloride and Water for injections
What Rapitil Eye Drops look like and contents of the pack
Rapitil Eye Drops are available as a clear yellow solution supplied in a 3 ml
or 5 ml plastic dropper bottle. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

RAPITIL

4. Possible side effects
Like all medicines, Rapitil Eye Drops can cause side effects, although not
everybody gets them.
Stop using Rapitil Eye Drops and see a doctor as soon as possible if:
• The itching, redness or swelling gets worse. You may be allergic to these
drops
Talk to your doctor or pharmacist if any of the side effects gets serious
or lasts longer than a few days, or if you notice any side effects not
listed in this leaflet:
Common (affects 1 to 10 people in a 100)
• Stinging or burning in your eyes or blurring of eyesight. This should only
last for a short time and occurs immediately after using the eye drops
• Change in the way things taste
Uncommon (affects 1 to 10 people in a 1,000)
• Mild eye irritation

PAD
Tech. specif.
Tech. area
Size (mm)

522013 / 606210

Adults and the Elderly only
Perennial allergic conjunctivitis:
• One drop into each eye twice each day
• This can be increased to four times each day if needed
• Use the drops regularly
Children under 6 years
This medicine is not recommended for children aged less than 6 years.
If you take more Rapitil Eye Drops than you should
If you use more Rapitil than you should, talk to your doctor or go to a
hospital straight away. Remember to take any medicine that is left with you
so the doctor knows what you have taken.
If you forget to use Rapitil Eye Drops
If you forget a dose, use your drops as soon as you remember. However, if it
is nearly time for your next dose, skip the missed dose. Do not use a double
dose to make up for a forgotten dose.
If you stop using Rapitil Eye Drops
Keep using the eye drops for as long as your doctor or pharmacist advises
you. If you stop using Rapitil Eye drops too early, your allergy symptoms
may come back.

Date of creation
04/06/2015
By
F Nguyen
Date of modification By
Proof n°
1
Pantone
Colours
used: 1
Reflex Blue

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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